A Phase I Study of Humanized 3F8 Monoclonal Antibody in Patients with High-Risk Neuroblastoma and GD2-Positive Tumors

Protocol
11-009
Full Title
Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) in Patients with High-Risk Neuroblastoma and GD2-Positive Tumors
Phase
I
Purpose

3F8 is an antibody that attaches to neuroblastoma cells and helps focus a patient’s own immune system — especially white blood cells — to attack neuroblastoma cells. Conventional 3F8 is made from mouse cells.

In this study, investigators want to find the optimal dose of humanized 3F8 (Hu3F8) that can be given to young patients with neuroblastoma who have a high risk of relapsing with standard treatment. Hu3F8 is made to be more like the human immune system than a mouse’s immune system, so it may be associated with fewer side effects in patients than standard mouse-derived 3F8.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-risk neuroblastoma or a metastatic tumor that expresses the GD2 protein.
  • Patients’ cancers must persist or have returned despite prior treatment.
  • Prior treatment with murine (mouse-derived) 3F8 is permitted.
  • Patients must be at least age 1 but younger than 22.

For more information about this study and to inquire about eligibility, please contact Dr. Ellen Basu at 212-639-5204.

Disease(s)
Neuroblastoma
Sarcomas: Osteosarcoma
Sarcomas: Soft Tissue Sarcoma
Locations